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Qualified person (l. 68/99)

Pioltello
Air Liquide
Pubblicato il Pubblicato 5h fa
Descrizione

Ph3Air Liquide Italy – Company Overview /h3 pPresent in Italy since 1909, Air Liquide is the market leader in industrial gases and related services and technologies. Using an industrial and commercial structure spread throughout the country and a pipeline network of 600 km, Air Liquide Italy supplies around 100 thousand direct and indirect customers, from large companies to small artisans. /p pAir Liquide Italy has three Business Lines: /p ul liLarge Industries: provides technical gases and related products in an enlarged offer with high added value for large industrial customers by means of specific delivery systems (pipelines) /li liIndustrial Merchant: develops the production and sale of liquids and conditioned gases, manages the on site production and services for industrial customers. /li liElectronics: develops the market related to high purity gases for the semiconductor industry. /li /ul pThrough innovative technologies and services, Air Liquide Italy offers high value-added solutions that improve both industrial performances and environmental impact. /p h3How will you CONTRIBUTE and GROW? /h3 pThe resource will be inserted inside the Production Center of Limito. /p pAs QP backup, the candidate will be responsible for the release of medicinal gases as defined by Art. 52 – D.Lgs. 219/2006, the conditions of the marketing authorization and the implementation and operation of Good Manufacturing Practices (GMP). As a quality control officer, the candidate guarantees the compliance of gases (industrial, food and medicinal) according to GMP and D.Lgs. 219/2006. /p pAs QP backup, the candidate will collaborate with the Production Manager to implement the company’s production plans, ensuring deliveries to clients in compliance with company specifications and contracts, legal regulations in health, safety, hygiene and environment, and company procedures. The candidate will continuously interact with the Quality Unit of the Production Center to receive ongoing feedback on compliance with specifications. /p pAs a quality control officer, the candidate will be inserted in the Quality Unit, carrying out analysis, inspecting pre-release batches, verifying instrument calibration and drafting technical documentation such as CoA and CoC, with the goal of ensuring zero customer complaints and zero document non-conformities. /p h3QP core activities: /h3 ul liRelease batches: responsible for releasing batches of pharmaceutical oxygen and active substance, ensuring they are produced and controlled in compliance with legal norms, production authorization and Quality Agreements. /li liDocumentation and certification: attests control operations on appropriate documentation and ensures its retention for possible inspections by health authorities. /li liIrregularity management: promptly communicates to AIFA and company managers any irregularities detected in medicinal products already on the market. /li liSupervision and collaboration: exercises functional supervision over GMP aspects towards Quality Control and the Production Manager, collaborates in handling complaints and recalling non-conforming products from the market. /li liValidation and control: verifies and validates changes with potential impact on production, participates in qualification of critical equipment and keeps the Validation Master Plan (VMP) updated. /li liReporting and review: drafts the Annual Product Review (APR) in collaboration with other functions for continuous validation of the manufacturing process. /li liInspections and training: actively collaborates in health authority inspections and ensures GMP/Pharma training for all relevant staff. /li liWaste management support: assists the Waste Management Manager in updating documentation, dealing with suppliers for waste removal and compiling the MUD. /li /ul h3Quality Control core activities: /h3 ul liVerify correct calibration and operation of analysis instruments per company procedures. /li liVerify analytical results and production batch records for compliance. /li liCompile mandatory technical documentation, including CoA, CoC, batch records, calibration sheets and maintenance reports. /li liCollaborate in resolving non-conformities, out-of-specification and quality complaints regarding gases. /li liPerform qualification and validation tests for analytical instrumentation. /li liContribute to the definition of specifications, analytical methods and procedures impacting gas quality. /li liEnsure adherence to operating instructions for maintenance and calibration of critical equipment. /li liVerify analyses in case of product adjustments from other authorized production units. /li liParticipate in supplier identification impacting gas quality. /li /ul h3Match Criteria /h3 pbIstruzione: /b Laurea in chemistry and pharmaceutical technology, pharmacy, industrial chemistry, biological sciences with studies path as per Art. 52 – D.Lgs. 219/2006. Professional qualification and registration in the professional register and QP qualification. /p pbProfessional experience: /b Preferable to have performed practical activities concerning qualitative analysis of medicines, quantitative analysis of active substances, tests and verifications necessary to guarantee medicinal quality for at least two years in companies authorized to produce medicines. /p pbCompetences: /b /p ul libTechnical skills: /b knowledge of Good Manufacturing Practices and specific requirements of medicinal gas production, health and hygiene. /li libSoft skills: /b flexibility, teamwork, priority management, results orientation, problem‑solving, precision, analytical ability. /li libLanguage: /b intermediate English. /li /ul pThe recruitment is exclusively targeted at candidates belonging to the Protected Categories pursuant to Law 68/99. /p h3Our Differences make our Performance /h3 pAt Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. /p pWe welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world. /p /p #J-18808-Ljbffr

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